You are on page 1of 54

FDA WEBINAR

March 12, 2010


We are a group of six women including a mother whose daughter died after receiving
the Gardasil vaccine and another whose daughter suffered adverse reactions. Over the last
three to four years we have offered our time to research, educate and communicate the
potential dangers of the HPV vaccines. We represent a growing global community of parents,
journalists, and researchers who are dedicating energy, time and knowledge to assist those
families desperate to understand what happened to their daughters, and to bring out the truth
about Gardasil and Cervarix so there will be “one less” instead of “one more” innocent victim.

We speak on behalf of families around the world to bring justice to the thousands of
adversely injured girls and the estimated hundreds of girls who have died from Gardasil and
Cervarix.
United States United Kingdom Netherlands India

Australia Germany New Zealand Argentina

France Canada Spain Finland


Sweden
Webinar Researchers & Participants

Karen Maynor New Mexico mother of deceased daughter Political Activist

Rosemary Mathis North Carolina mother of injured daughter VAERS Data

Freda Birrell Scotland political lobbyist Global Reports

Janny Stokvis Netherlands research analyst VAERS Data

Cynthia Janak Illinois research journalist Histamine and IgE


Research, VAERS Data

Leslie C. Botha Colorado women’s health activist Menstrual Cycle


broadcast journalist Evaluation
There are thousands of concerned parents with tens of thousands of questions
Seven are addressed in this presentation and are substantiated with research and data.

I. My daughter is now sick after the HPV vaccination and has warts on her hands and
feet. Is HPV really only an STD?

II. My daughter has received an irregular pap test two years after the vaccinations. I
thought the vaccine was supposed to prevent this?

III. Why is my daughter so ill now when she was always so healthy before the
vaccination?

IV. After reporting my daughters reactions to VAERS (Vaccine Adverse Event Reporting
System) I became curious to see how many other girls are like my daughter. There are so many
I am now afraid my daughter will not get better.

V. I am 18 and my friends and I got the shots. Why did I get an autoimmune disorder
and they did not?

VI. How does the side effects my daughter is experiencing compare with other children?

VII. Why did my daughter die?


Global Parental Concerns
The international stories, spreadsheet and graphs that have been prepared represent a
sample of the injuries occurring to adolescent girls globally.

When reading the many reports of girls adversely affected it becomes quickly evident
that the symptoms they are experiencing are part of a pattern of events that are similar
wherever the HPV vaccines are administered around the world.

The handouts and in particular the graphs demonstrate this very point.
Graph 3 Graph 4
United States of America Spain
% of Symptoms of the 34 young ladies represented % of Symptoms of the 17 young ladies represented
60
80 50
70
60 40
50 % 30
% 40
30 20
20 10
10
0 0
D on

En zin e/p gue


C

D es Fa

Fa ep s/N ncr

Jo da s sis DE

M s o sc

R aly al C n s
R he s an
H ial lit us atit

Lo t/M es

M co
H r L ara /MS

Se pir all e
Pa st Vis Pa

Sy r r ie
ig i c
Ch
D ron
D es i c F

Fa cepess pan e

Jo da ss lys

M s us

R r alyual sio .
Re he is h

hr

iz tiv ti

as si h
es s/
En zin ive tig

Hacial hal Nau...

Loint/ he s

M ncoes y/Hies

en f le
ai P is ea is

is pe
H ir L Pa tis/ sea

Sespi s/a

ea o ly /
Panst f V le

Sy zu ato erg

c es a
c ha a e

in h
s u

i z ato rg
ig
iz t a

as s C n
e o c

r ru io in

n es y/H s
is p
ea o ra ...

ce
s

u
c e e ear

lla
c
M s

s
r r
r i ..

lla

ne
c

ne

ou
l
/ u
/
i

ou

s*
ea
...

s*

ge

rt
i

s
t

M
Gardasil and Cervarix
Synopsis
Gardasil

Cervical cancer is an important public health problem in the United States, with 9,710
new cervical cancer cases and 3,700 deaths due to cervical cancer projected for 2006(1).
Cervical cancer has been associated with human papillomavirus (HPV) infection.
Merck, Inc., began a clinical development program in 1997 with a recombinant HPV
virus-like particle (VLP) vaccine for the prevention of cervical cancer. pg.8

Reviewer’s Comment: In all analyses, there is a positive impact in prevention of these


dysplasias in those who have not been exposed to the relevant HPV type … pg. 29

(Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18)
Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16
and 18. 2008 09 11,)

1. Jemal A et al. Cancer Statistics, 2006. CA: A Cancer Journal for Clinicians 2006;56:106-30.
Gardasil and Cervarix
Synopsis
Cervarix
Cervarix is intended for the vaccination of girls and women 10-25 years of age for the
prevention of the following diseases caused by HPV types 16 and 18 included in the
vaccine:
• Cervical cancer
• Cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ
• Cervical intraepithelial neoplasia (CIN) grade 1, pg.14

Biological changes in the cervix around the time of puberty render young girls particularly
susceptible to HPV infection [Moscicki, 2005]. This period coincides with the initiation of
sexual activity, which is considered an important factor in the acquisition of oncogenic
HPV infection. To achieve the maximum benefit from a prophylactic vaccine, vaccination
should occur before sexual debut. Pg. 42
(Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, Vaccines and Related Biological Products Advisory
Committee (VRBPAC), Briefing Document, September 9, 2009,)
Post Vaccine
Global Parental Concerns

I. My daughter is now sick after the HPV


vaccination and has warts on her
hands and feet.
Is HPV really only an STD?
HPV Transmission in Infants and Children
Studies regarding HPV Contact

Cadernos De Saude Publica, Rio deJaniero, 21(4): 1006-1015, jul-ago, 2005


http://www.scielo.br/pdf/csp/v21n4/03.pdf
Although epidemiological trials suggest the possibility of non-sexual
transmission, there is evidence of vertical transmission, presumably occurring
during passage of the fetus through an infected birth canal. The virus could also
be transmitted by ascending infection, principally after premature rupture of
membranes. Pg. 1006

Acta Microbiologica et Immunologica Hungarica 48(3-4) pp 511-517 (2001)


http://www.akademiai.com/content/h32q968j22183585/

Introduction of the polymerase chain reaction (PCR) revealed that HPV


infections are much more common among young asymptomatic women
than it had been previously suspected. The side-specificity of genital HPVs
led to the assumption that HPVs were primarily transmitted by sexual
contact. However, since HPVs have been detected in virgins,
infants/children and juvenile laryngeal papillomatosis was shown to be
caused by these viruses, it became acknowledged that HPVs may be
transmitted by other – non-sexual – routes as well. Pg. 511
HPV Transmission in Infants and Children
Studies regarding HPV Contact

Journal of Clinical Microbiology, January 2005, p. 376-381, Vol. 43, No. 1


http://jcm.asm.org/cgi/reprint/43/1/376
… nonsexual modes of HPV transmission also have to be considered. These
include vertical transmission from parents to infants, horizontal transmission
from other family members and those in close contact with the child,
autoinoculation from one site to another, and possibly indirect transmission via
fomites.

Journal of Medical Virology, Vol 61 issue 1, pp 70-75 (2000)


http://cat.inist.fr/?aModele=afficheN&cpsidt=1403036
Before immunisation programmes can be designed, however, it is necessary to
know the age of acquisition and all routes of infection for these viruses. Sexual
transmission is well documented and vertical transmission has also been
demonstrated, although the frequency of transmission remains controversial. We
previously showed that vertical transmission frequently results in persistent
infection, and now present data on the prevalence of HPV-16 DNA (the most
prevalent high-risk HPV type) in healthy children.
Journal of Medical Virology, Vol 71 issue 4, pages 593-598 (2003)
http://www3.interscience.wiley.com/journal/106056791/abstract
It is concluded that HPV-16 DNA in the oral cavities of children is a transient event
and is most probably acquired from their peers.
Post Vaccine
Global Parental Concerns
II. My daughter has received an irregular pap
test two years after the vaccination series.
I thought the vaccine was supposed
to prevent this?
By sledmom | Reply | (2) replies | Private Message me

January 2th
2009
8:20 AM
A good friend of mine, a person I have known for 30 years, told me yesterday that her son's girlfriend, a college
student, had surgery over the Christmas break for cervical cancer. This is her second surgery, and both surgeries
were paid for by the manufacturer of Guardasil. By paying for these surgeries, it seems clear that the company is
accepting responsibility for what happened to her. Apparently, because this girl had a weak immune system,
Guardasil actually caused the very thing it was intended to prevent--cervical cancer.
Neither my friend nor I had never heard anything like this before, and I am wondering if others know of girls who
have actually gotten cervical cancer after receiving Guardasil.

According to the National Vaccine Information Center there are 272 events with Vaccine that is HPV or HPV4 and
Symptom is Smear cervix abnormal
http://www. medalerts.org
HPV Vaccines - Are They Safe for
Seropositive Females?
VRBPAC Background Document
Gardasil™ HPV Quadrivalent Vaccine
May 18, 2006 VRBPAC Meeting

Table 17. Study 013: Applicant’s analysis of efficacy against vaccine-relevant HPV
types CIN 2/3 or worse among subjects who were PCR positive and seropositive for
relevant HPV types at day 1. [From original BLA, study 013 CSR, Table 11-88, p. 636]
HPV Vaccines - Are They Safe for
Seropositive Females?
VRBPAC Background Document
Gardasil™ HPV Quadrivalent Vaccine
May 18, 2006 VRBPAC Meeting

Table 19. Study 013: Analysis of efficacy against vaccine-relevant HPV types CIN
2/3 or worse among subjects who were PCR positive and/or seropositive for the
relevant HPV type at day 1. [From additional efficacy analyses requested by CBER and
submitted March 15, 2006, table 1e-2, p. 13.]
HPV Vaccines - Are They Safe for
Seropositive Females?
CERVARIX
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Briefing Document
September 9, 2009

Table 15 Study HPV-008: overview of vaccine efficacy against histological


lesions associated with HPV-16/18 (by PCR) in HPV DNA positive
subjects at baseline (TVC-1)

As expected, the vaccine did not show a therapeutic effect in subjects HPV DNA positive
at baseline for the type considered in the evaluation (Table 15). Pg 62
HPV Vaccines - Are They Safe for Seropositive Females?
Does HPV screening take place before vaccination?
No screening takes place prior vaccination with either of the HPV vaccines!

"In June 2009, representatives from the Society, ACOG (American College of Obstetricians and
Gynecologists), and approximately 25 other organizations met to discuss cervical screening and
management for adolescents. There was general consensus that new screening guidelines should
recommend against adolescent screening and that screening should begin at age 21," said
Saslow. "The Society will formally review the evidence and update our cervical cancer screening
recommendations in the coming year." *

When does screening take place?

• United States 25 years old


• Scotland 20 years old
• England/Wales 25 years old

ACOG Revises Cervical Cancer Screening Guidelines, Article date: 2009/11/20,


http://www.cancer.org/docroot/NWS/content/NWS_1_1x_ACOG_Revises_Cervical_Cancer_Screening_Guidelines.asp
HPV Vaccines are They Safe for
Seropositive Females?
HPV screenings do not take place prior to vaccination with either
Gardasil or Cervarix

The Problem

1. An infant can contract HPV at birth

2. A child can contract HPV by lateral transmission

3. Young girls and women are having intercourse at an earlier age

4. New pap recommendations will push initial screenings back to age 25


Post Vaccine
Global Parental Concerns

III. Why is my daughter so sick now when


she was always so healthy
before the vaccination?
Gardasil "New Medical Conditions"
Clinical Review of Biologics License Application Supplement
September 11, 2008
TABLE 79
New Medical Conditions After Day 1 in Studies HPV-007, -013, -015,
-016, -018 in the Safety Population (Final Close-out data)

VRBPAC Background Document


Gardasil™ HPV Quadrivalent Vaccine
May 18, 2006 VRBPAC Meeting

Table 32. Detailed Safety Population: Number (%) of subjects who


reported systemic adverse reactions of 2% or greater in the 15 days
following receipt of study vaccine.
[From original BLA, safety summary, Table 2.7.4:14.]
Cervarix - Solicited Adverse Events
CERVARIX
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Briefing Document
September 9, 2009

Table 28 Pooled safety analysis: percentage of doses (overall/dose) followed by solicited general
symptoms reported during the 7-day (Days 0-6) post-vaccination period (Total Vaccinated Cohort, 10-
25 year olds)
Comparison of Gardasil and Cervarix
VAERS Reported Adverse Reactions

Adverse Event Gardasil Cervarix


Fatigue 2.6% 35.5%
Fever* 8.8% 5.5%
GI** 5.6% 13.9%
Headache 26.4% 31.3%
Rash/Skin disorder 3.5% 4.2%
Arthralgia 1.2% 10.4%
Myalgia 2.0% 31.0%
Urticaria n/a 3.3%

Gardasil numbers are taken from table 322 of May 18, 2006 VRBPAC Meeting Background Document
Cervarix numbers are taken from Table 28 of the VRBPAC Briefing Document, September 9, 2009
* Computation of table 323 of May 18, 2006 VRBPAC Background Document
** Computation of gastrointestinal including nausea, vomiting, diarrhea, and/or abdominal pain.
Analysis of CDC numbers of administered HPV vaccine.
National, State, and Local Area Vaccination Coverage Among Adolescents Aged 13--17
Years --- United States, 2008

For HPV4, 37.2% of adolescent females had initiated the vaccination series (≥1 dose) in 2008,
compared with 25.1% in 2007, and 17.9% of females had received ≥3 doses. Among adolescent
females who initiated the HPV4 series, 79.4% had received their first dose at least 24 weeks
before the interview date (the minimum period in which to complete the series); of these,
59.6% (95% confidence interval [CI] = 55.5--63.5) had received ≥3 doses.

Census data years 2008 2007


15 to 19 years 10,487,094 10,466,821
CDC estimates
13 - 17 years old

> 1 dose
2007 25.1% 2,632,261
2008 37.2% 3,901,199
total 6,533,460
> 3 doses 1,169,489
2007 & 2008 17.9% 1,877,190
Difference 4,656,270 28.7% 71.3%

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5836a2.htm September 18, 2009 / 58(36);997-1001


Post Vaccine
Global Parental Concerns
IV. After reporting my daughters reactions to
VAERS (Vaccine Adverse Event Reporting
System) I became curious to see how many other
girls are like my daughter.
There are so many I am now afraid my daughter
will not get better.
HPV vaccine trend of injury by classification
1000 LIFE THREATENING
800
600 27%
400 74%
200 62% ALL VACCINES
0
HPV VACCINE
Female All
Ages Female age
6-17 Female age
18-29
25000
ER VISIT
20000
33%
15000
10000
67% ALL VACCINES
5000 66% HPV VACCINE
0
All female
Female age 6-17
Female age 18-29
HPV vaccine trend of injury by classification
6000 HOSPITALIZED

4000 28%

2000 74%
ALL VACCINES
59%
0 HPV VACCINE

Female All Ages


Female age 6-17
Female age 18-29
400
44% EXTENDED HOSPITAL STAY
300
200
85%
100 ALL VACCINES
82%
0 HPV VACCINE

Female All Ages


Female age 6-17
Female age 18-29
HPV vaccine trend of injury by classification
10000 DID NOT RECOVER
8000 36%
6000
4000
77% ALL VACCINES
2000 75%
HPV VACCINE
0

Female All Ages


Female age 6-17
Female age 18-29

1500 DISABLED
1000 36%

500
85% 72% ALL VACCINES
0 HPV VACCINE

Female All Ages


Female age 6-17
Female age 18-29
HPV vaccine trend of injury by classification

400
DIED
300

200 13%

100 ALL VACCINES


81%
69% HPV VACCINE
0

Female All
Ages Female age
6-17 Female age
18-29
VAERS Reported Vaccine Injuries
VAERS Reported Vaccine Injuries for Multiple
Vaccinations
VAERS Comprehensive Analysis

Submission date 05/31/06 Submission Date 06/01/06


on/before 05/31/06 Difference on/after 06/01/06 Difference
% %
male female male female
0 - 2 year olds 35216 30719 4497 14.6% 9382 8091 1291 16.0%
3 - 5 year olds 12868 11679 1189 10.2% 3945 3687 258 7.0%
6 - 10 year olds 3990 3743 247 6.6% 1937 2308 371 16.1%
11 - 13 year olds 2980 3099 119 3.8% 1987 3592 1605 44.7%
14 - 16 year olds 1858 2587 729 28.2% 940 4746 3806 80.2%
17-19 year olds 1589 2665 1076 40.4% 782 4097 3315 80.9%
20 - 26 year olds 3617 6496 2879 44.3% 1315 5238 3923 74.9%
27 - 30 year olds 2059 4569 2510 54.9% 596 1415 819 57.9%

*Note: the numbers for 06/01/06 reflect reporting through October of 2009.
VAERS Comprehensive Analysis

2005 % 2006 % 2007 % 2008 % 2009 %


female female female female female
0 - 2 yr olds 2022 8.2% 2245 12.4% 2476 16.8% 2662 13.4% 1462 15.0%
3 - 5 yr olds 616 21.8% 638 17.1% 745 5.0% 772 5.6% 577 6.1%
6 - 10 yr olds 316 10.4% 325 6.2% 637 11.9% 697 13.9% 335 19.1%
11 - 13 yr olds 138 23.9% 210 11.4% 812 41.5% 943 38.1% 627 34.3%
14 - 16 yr olds 124 4.8% 216 36.6% 1001 76.5% 1327 82.8% 719 78.9%
17 - 19 yr olds 218 41.7% 237 37.6% 1140 84.5% 1366 83.5% 619 80.6%
20 - 26 yr olds 384 31.0% 494 49.6% 1592 74.6% 1915 78.5% 933 71.3%
27 - 30 yr olds 183 42.1% 245 57.6% 366 55.2% 411 58.9% 231 55.8%

*Note: the numbers for 2009 reflect reporting through October of 2009.
Post Vaccine
Global Parental Concerns

V. I am 18 and my friends and I received


the Gardasil series. Why do I have an
autoimmune disorder and they do not?
Demographics of Girls Affected by
Adverse Reactions

• Athletic

• Overweight

• Vaccination during Paramenstrum


Demographics of Girls Affected by
Adverse Reactions
Studies of Female Athletes
Diurnal Profiles of Testosterone and Pituitary Hormones
Suggest Different Mechanisms for Menstrual
Disturbances in Endurance Athletes

We found that 24-h profiles of testosterone, LH, and PRL were


positively correlated and cortisol negatively correlated with the
number of menstruations during the last year in these athletes.
However, the endocrine profiles in amenorrheic and
oligomenorrheic athletes were apparently different. Amenorrehic
athletes displayed a hormonal pattern in agreement with
hypothalamic inhibition. In contrast, oligomenorrheic athletes
had higher 24-h secretion of testosterone than all other
groups.

The Journal of Clinical Endocrinology & Metabolism 89(2):702–707


Printed in U.S.A. Copyright © 2004 by The Endocrine Society
doi: 10.1210/jc.2003-030306
Demographics of Girls Affected by
Adverse Reactions
Studies of Female Athletes
THE IMPORTANCE OF HORMONES IN FEMALE ATHLETIC COMPETITION*

The pre-event rise in males averages nine percent whereas in females it increases by twenty-four
percent. During the competition itself women increase their testosterone production by forty-
nine percent while in males it increases on average fifteen percent.

"We are not sure why women's testosterone elevation prior to competition is so much greater than it is in
men. It is probably due to the fact that every day levels of testosterone are four times higher in men than
they are in women. To effectively meet the challenge a higher production rate may be necessary," explains
Dr. Alan Booth, Distinguished Professor of Sociology, Human Development and Family Studies, and
Demography at Pennsylvania State University.

"Among women, pre-game testosterone increases were significantly correlated with reports of
being focused just prior to the game, just as it is associated with arousal in men," Booth says. "Unlike
pre-game increases in men, the pre-game increase among women was unrelated to the perceptions of
how easy or difficult the opponent was thought to be prior to the game. Men seem to adjust their pre-
game rise to the perceived strength of the opponent."

* http://www.collegesportsscholarships.com/steroids-testosterone-women.htm "College Sports Scholarships"


Demographics of Girls Affected by
Adverse Reactions
Studies of Overweight Females
Link Between Polycystic Ovary Syndrome and
Obesity Involves Insulin *
Hyperinsulinemia also stimulates the ovaries to make more male
hormones (testosterone and androstenedione) and lowers the liver’s
ability to clear these hormones from the blood. Higher blood levels of
male hormones contribute to PCOS symptoms including acne, male-
pattern hair growth (on face or body) or balding, and lack of
ovulation.

Testosterone Concentrations in Women Aged 25–50 Years:


Associations with Lifestyle, Body Composition, and Ovarian
Status **
The greater circulating levels of testosterone with obese women and
smokers suggest that testosterone may be an important contribution to
those disease conditions where obesity and smoking are risk factors,
including cardiovascular disease.

* http://win.niddk.nih.gov/notes/summer04/winnotes_summer04.htm The full report, “Pathogenesis of polycystic


ovary syndrome: What is the role of obesity?” appears in Metabolism (2004;53:358-376).
** http://aje.oxfordjournals.org/cgi/reprint/153/3/256 American Journal of Epidemiology, Copyright © 2001 by The Johns
Hopkins University School of Hygiene and Public Health, Vol. 153, No. 3, Printed in U.S.A.
“It’s All In Your Head”
Endocrine-disrupting chemicals
can undermine neurological and behavioral development

My daughter had 2 Gardasil vaccines and approximately a year later has tested positive for
high-risk HPV. We also believe that her HPV is the result of the vaccines because: she did not
have HPV when she received the vaccines; she suffered SEVERE side effects from them which
incapacitated her for 2 1/2 months; and she continues to experience menstrual problems
even though it has been over a year. Now the news that she has precancerous, high-risk HPV.
"
Polycystic Ovarian Syndrome – Infertility - Occurrence of Cervical Lesions – Hair Loss

New evidence is especially worrisome because it underscores the exquisite sensitivity of the developing nervous
system to chemical perturbations that result in functional abnormalities. Moreover, the consequences of these
perturbations depend upon the stage of development during which exposure occurs and are expressed in different ways at
different times in life, from birth through to advanced age.

Because the endocrine system is sensitive to perturbation, it is a likely target for disturbance. In contrast to natural
hormones found in animals and plants, some of the components and by-products of many manufactured organic
compounds that interfere with the endocrine system are persistent and undergo biomagnification in the food web, which
makes them of greater concern as endocrine disruptors.

Statement from the work session on environmental endocrine disrupting chemicals: neural, endocrine and behavioral effects.
Erice,Sicily November 1995.
Demographics of Girls Affected by
Adverse Reactions
Studies on Menstrual Cycle Evaluation
Annovulatory, Oligomenorrheal and Dysmenorrheal Cycles

Impact of stress, gender and menstrual cycle on immune system: possible role of nitric oxide
http://www.ncbi.nlm.nih.gov/pubmed/11935378
Stress is a factor found to be involved in the etiology of many diseases. Gender and menstrual cycle phases are other factors
affecting the predisposition of individuals for certain diseases. Results from animal and human studies suggest that the
distribution of immune system cells may change at different phases of the menstrual cycle.
Sex Differences in Stress Response Circuitry Activation Dependent on Female Hormonal Cycle
http://www.jneurosci.org/cgi/content/abstract/30/2/431
Understanding sex differences in stress regulation has important implications for understanding basic physiological
differences in the male and female brain and their impact on vulnerability to sex differences in chronic medical disorders
associated with stress response circuitry.
Influence of menstrual cycle on NK activity
http://www.journals.elsevierhealth.com/periodicals/jri/article/PIIS0165037800000917/abstract
Natural killer (NK) cells* are CD3- CD56+ and/or CD16+ cytotoxic lymphocytes that mediate first-line defense against
various types of target cells without prior immunization…. results showed that (1) NK cytotoxicity was higher in the
follicular than in the luteal phase of the menstrual cycle
Demographics of Girls Affected by
Adverse Reactions
Menstrual Cycle Evaluation Studies
Testosterone levels and cognitive functioning in women with polycystic ovary syndrome
and in healthy young women
http://www.ncbi.nlm.nih.gov/pubmed/17433328
Women with PCOS had significantly higher levels of free T (estimated by the free androgen index) and
demonstrated significantly worse performance on tests of verbal fluency, verbal memory, manual dexterity, and
visuospatial working memory than the healthy control women.

Hair Loss
http://mayoclinic.com/health/hair-loss/DS00278/DSECTION=causes
Due to hormonal changes, irritation or damage, some hair follicles have a shorter growth phase and produce
thinner, shorter hair shafts.

Alopecia areata. This is classified as an autoimmune disease, but the cause is unknown. People who develop
alopecia areata are generally in good health. A few people may have other autoimmune disorders, including thyroid
disease. Some scientists believe that some people are genetically predisposed to develop alopecia areata and that a
trigger, such as a virus or something else in the environment, sets off the condition.
Demographics of Girls Affected by
Adverse Reactions
Studies on Menstrual Cycle Evaluation
Luteinizing hormone provides a causal mechanism for mercury associated disease
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WN2-4XP3C11-
2&_user=10&_coverDate=11%2F13%2F2009&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1
&_urlVersion=0&_userid=10&md5=088cbd4b1b6837e023db2ef62e4df6ba#cor1
Previous studies have demonstrated that the pituitary is a main target for inorganic mercury (I-Hg) deposition and
accumulation within the brain. My recent study of the US population (1999–2006) has uncovered a significant, inverse
relationship between chronic mercury exposure and levels of luteinizing hormone (LH). This association with LH
signifies more than its presumed role as bioindicator for pituitary neurosecretion and function.

Brief Assessment of Aluminum Exposure and Endocrine System


http://www.safeminds.org/mercury/docs/Brief%20Assessment%20of%20Aluminum%20Exposure%20and%20Endocrine%20Disruption.pdf
It is thought that inflammation resulting from aluminum exposure may induce learning and memory deficits [39].
Certainly, targeted effects on the endocrine system may affect immune-modulation and produce a pro-inflammatory
cascade that responds to targeted aluminum deposition in the hippocampus with resultant neurotoxicity.

Heavy Metals and Fertility


http://www.informaworld.com/smpp/content~content=a713851573&db=all
Thus, the hypothalamic-pituitary-ovarian axis can be affected by heavy metals either directly or indirectly through
modifications of the secretion of prolactin, adrenocortical steroidsor thyroid hormones. In the ovary itself,
accumulation of heavy metals impairs the production of estradiol and progesterone.
Demographics of Girls Affected by
Adverse Reactions
Menstrual Cycle Evaluation Studies

Hormone Allergy
http://onlineallergycenter.com/folder/research_abstracts/Hormone_Allergy_AJRI_3_10_06.pdf
Many disorders have been associated with menstrual cycle influences, including acne, asthma, hereditary
angioedema, apthous ulcers, Behc¸et syndrome, porphyria, epilepsy, myasthenia gravis, allergic rhinitis
and migraines.1–10 A recent review of autoimmune progesterone dermatitis11 describes an allergic
reaction to progesterone that can lead to severe dermatitis and anaphylaxis. Geber12 described the first documented
case of cyclic urticaria associated withthe menstrual cycle in 1921. He suggested a terminology of hormone allergy
after demonstrating a flare in the disease by administering the patient’s own pre-menstrual serum.1

Immunological Adjuvants and Vaccines


http://www.amazon.com/Immunological-Adjuvants-Vaccines-Nato-Science/dp/0306433869
…it has now been revealed that it is the aluminum which is put into vaccines as an adjuvant which causes production
of IgE…the antibody of allergy and anaphylactic shock.

Histamine Metabolism During the Menstrual Cycle


http://www.ncbi.nlm.nih.gov/pubmed/973560
At mid cycle an increase in the urinary excretion of histamine metabolites was sometimes evident and a statistically
significant correlation could be established between MeHi and estrogen in urine. These results may support previous
findings of histamine release by estrogens in uterine tissue but may also reflect an elevated histamine formation. The
allergic woman excreted constantly increased amounts of histamine and its metabolites, especially when her allergic
symptoms became aggravated premenstrually.
Post Vaccine
Global Parental Concerns

VI. How do the side effects my daughter is


experiencing compare with other children?
Gardasil Girls give the Silent Faces of Autism a Voice

Vaccinations, cytokine storms, and autism


http://www.generationrescue.org/binstock/090711-autism-by-cytokine-
storms.htm

The CDC's list of vaccination side-effects (3) seems based upon individual vaccines. As
reported by many parents of autistic children who regressed after vaccination episode, the
mild, moderate, and supposedly "rare" side effects of vaccinations resemble post-vaccinal
symptoms manifested by their child.

Apparently not addressed by the CDC's list of adverse effects of individual vaccinations is
whether or not a child who is injected with multiple vaccines during one incident is more
likely (a) to experience one or more of the side effects, (b) to develop a more severe reaction
(eg, fever related to seizures), or (c) to develop symptoms consistent with vascular pathology
or brain damage. Examining specific vaccine's side effects (4) offers clues regarding what
might be more likely to occur in some individuals when, for instance, the DTaP, MMR, and
another "routine" vaccine are injected during the same incident.
Reported Adverse Reactions Partial Summary
Gardasil and Cervarix

Auto immune disorders


Paralysis
Guillane Barre Syndrome
Seizures
Migraines
Blindness or temporary disruption of vision
Hearing Loss (predominate with Cervarix VAERS reports)
Memory Loss, inability to concentrate, brain fog

Chemical Menopause Symptoms


facial hair, disruption of menses, drastic mood swings (hormone
imbalance), painful menses, poly cystic ovarian syndrome*
Circulation Issues
heart palpitations, numbness in extremities, fainting, drops in blood
pressure, pain in chest
http://pcos.about.com/od/normalmenstrualcycle/f/androgens.htm
Post Vaccine
Global Parental Concerns
VII. Why did my daughter die?
One less daughter, one less sister, one less aunt, one less niece, one less student,
one less future wife, one less future mother; one less woman who will make a
difference.

64 deaths reported in VAERS


17,400 adverse affects
ONE LESS! ....................................................................
-Shanna Jojola, sister of Megan

Not a day goes by that our family does not mourn the loss of our beautiful daughter, Megan Hild.
My oldest daughter, Shanna is traumatized by the fact that she encouraged Megan to get Gardasil.

I will not live with a cause of death unknown on her autopsy report. I will not tolerate the “expert’s”
who told me that Megan was ready to leave this life. I spoke with my daughter two hours before she
died. She was vibrant, beautiful, healthy and embraced her life, her future – her family and her
boyfriend.

Do not forget the guilt, grief and loss that the families are left with. They are the ones who carry the
burden of a life unnecessarily taken or a daughter damaged from the HPV vaccines.
-Karen Maynor
U.S. HPV Vaccine VAERS Reported Deaths
Presently there are 46 deaths referencing heart issues in the VAERS
reports in regards to the HPV vaccination.

3 Myocarditis -
1 Sudden Cardiac Death
7 Pulmonary Embolism/Blood Clots
5 Cardiac Arrest
1 Pulmonary Thromboembolus
1 Arrhythmia Due to Cardiomyopathy
1 “Viral insult to the heart”
1 Cardiovascular Collapse
1 Hypertrophic Cardiomyopathy
1 Acute Cardiac Arrhythmia
1 Cardiomegaly
6 Sudden Death
2 “Died in her Sleep”
15 Unknown
U.S. HPV Vaccine VAERS Reported Deaths
Autopsy Report – 18 year old female

1. “There was biventricular cardiomegaly”


2. “There was transmural replacement of myocytes by fibro-fatty tissue in the right
ventricular wall”
3. “There was also diffuse variable myocyte hypertrophy”

ARVD – Arrhymogenic Right Ventricular Dysplasia*

1. Is a cardiomyopathy (a disease of the cardiac muscle cells)


2. Affects about 1/5000 people
3. Is a known cause of sudden cardiac death in young people
4. Many cases of death occur in the home during sedentary activities
5. Symptoms - Abdominal pain, Decreased exercise tolerance, Dizziness, Dyspnea
‘difficulty breathing’ (especially with exertion), Fatigue, Mental confusion,
Palpitations, Syncope or fainting
The Problem
“Because of the extensive tissue degeneration that had occurred prior to autopsy, some of
these diagnostic findings could not be definitively identified.”
“Other main diagnostic criteria can only be assessed in living patients.”
*Arrhythmogenic Right Ventricular Dysplasia, ERIC L. ANDERSON, LT, MC (FS), USNR, Naval Air Station Jacksonville, Jacksonville, Florida,
American Family Physician, Vol. 73/No. 8 (April 15, 2006) http://www.aafp.org/afp/2006/0415/p1391.html
Global HPV Vaccine Reported Deaths
19 year old female - NZ
September 2008 - First HPV vaccination
“Developed hand warts”

November 2008 - Second HPV vaccination


“Warts returned. There were some warts under her nails which were really painful.”

March 2009 - Third HPV vaccination,


“Became more agitated”, “complained every so often about a weak arm and
tiredness”, “arm pain continued and she used to get pins and needles and tingling in
her hands for no reason”, “started dropping things”,

April 2009 – Adverse Reaction


“Night sweats”, “feeling clumsy”, “knocking things over”, “dropping things at work”,
“where in the past she’d just do it, she didn’t seem to know how. It was like re-
teaching a child.”, “where is her decision making gone? Why can’t she do simple
things any more?”

July 2009 – Adverse Reaction


“Intermittently complained of chest pain and a racing heart.”, “sore achy back and
abdominal pain”, “the warts returned”

August 2009 – Adverse Reaction


“Cold never got better”, “had quite a few headaches”, “skin changed…a lot more
pimples than normal”, “hair lanky”

September 2009 – Died in her sleep.


L-histidine , Histamine and the Heart

L-Histidine is an amino acid from which Histamine is derived. L-Histidine is an amino acid that the
human body cannot manufacture, hence, it must be obtained from your diet. When released from
mast cells, histamine causes vasodilation (relaxation or dilation of the blood vessel walls).

“Dr. Levi adds that it is important to put the relationship between arrhythmia and histamine in
perspective. Severe arrhythmias can also result from the release of large amounts of histamine
that occurs when there is a massive allergic reaction, such as anaphylaxis. This is because too
much histamine stimulates the heart's H2-receptors, which tends to cause arrhythmia. In most
myocardial ischemia, only a small amount of histamine is released in the heart”(1)

“In 1959, Prinzmetal et al described a syndrome of chest pain at rest secondary to myocardial
ischemia associated with ST-segment elevation.1 Exercise tolerance was characteristically
normal in these individuals, who experienced a cyclical pain pattern with most episodes
occurring in the early morning hours. This syndrome, known as Prinzmetal or variant angina, is
due to focal coronary artery vasospasm and may be associated with acute myocardial infarction
(MI), serious ventricular arrhythmias, and sudden death.” (2)

(1) Weill Cornell Scientists Reveal Action of a Histamine Receptor That May Lead to New Therapies for Heart Attacks
Studies with Human Cell Lines Show that Activation of the H3-Receptor Limits the Release of Arrhythmia-Causing
Noradrenaline, New York-Presbyterian, NEW YORK (Dec 20, 2001) http://nyp.org/news/hospital/histamine-receptor-
activation.html
(2) Coronary Artery Vasospasm
Author: Andrew P Selwyn, MD, MA, FACC, FRCP, Professor of Medicine, Harvard Medical School; Senior Physician and
Cardiologist, Associate Chief of the Cardiovascular Division(Academic Affairs), Brigham and Women's Hospital
Coauthor(s): James L Orford, MBChB, Clinical and Research Fellow in Cardiovascular Diseases, Department of Internal
Medicine, Brigham and Women's Hospital, Harvard Medical School, http://emedicine.medscape.com/article/153943-overview
Myocardial Ischemia

Myocardial ischemia develops when coronary blood flow becomes inadequate to meet myocardial
oxygen demand. This causes myocardial cells to switch from aerobic to anaerobic metabolism, with
a progressive impairment of metabolic, mechanical, and electrical functions. Angina pectoris is the
most common clinical manifestation of myocardial ischemia. It is caused by chemical and
mechanical stimulation of sensory afferent nerve endings in the coronary vessels and myocardium.
These nerve fibers extend from the first to fourth thoracic spinal nerves, ascending via the spinal
cord to the thalamus, and from there to the cerebral cortex.

Myocardial ischemia can result from (1) a reduction of coronary blood flow caused by fixed and/or
dynamic epicardial coronary artery (i.e., conductive vessel) stenosis, (2) abnormal constriction or
deficient relaxation of coronary microcirculation (ie, resistance vessels), or (3) reduced oxygen-
carrying capacity of the blood. (1)

“Collectively, our findings emphasize the multiplicity of protective roles played by H3R activation in
the setting of myocardial ischemia. Because excess norepinephrine release can trigger severe
arrhythmias and sudden cardiac death, negative modulation of norepinephrine release by H3R
agonists may offer a novel therapeutic approach to myocardial ischemia. “ (2)

(1) Angina Pectoris


Author: Jamshid Alaeddini, MD, FACC, Clinical Cardiac Electrophysiologist, Inland Cardiology Associates
Coauthor(s): Jamshid Shirani, MD, FACC, FAHA, Consulting Staff, Director of Cardiovascular Fellowship Program, Department of
Medicine, Division of Cardiology, Geisinger Medical Center, http://emedicine.medscape.com/article/150215-overview

(2) Decreased intracellular calcium mediates the histamine H3-receptor-induced attenuation of norepinephrine exocytosis from
cardiac sympathetic nerve endings, Randi B. Silver, Kumar S. Poonwasi, Nahid Seyedi, Sandy J. Wilson, Timothy W. Lovenberg,
and Roberto Levi, Edited by Louis J. Ignarro, University of California School of Medicine, Los Angeles, CA, and approved November 1, 2001
(received for review September 25, 2001) , http://www.pnas.org/content/99/1/501.full
Immune System Reaction - IgE
•HPV protocol requires that the vaccine be administered as a series of three shots. This is
called challenge and re-challenge.*
•The only immune response cell that is monitored is the IgG antibody which is the most
common.
•The IgE antibody** is not monitored and is known to be the most damaging to the
body.
What we do know

1. VAERS reports after June 2006 show that the HPV vaccines comprise 27% of all
vaccine adverse events.
2. There are reports of auto-immune disease such as ALS, MS, etc.
3. Young girls and women are experiencing adverse events months to years after the
initial vaccinations.
4. Immune response has been studied for at least 36 months with a slow decline in anti-
bodies. Based on this, efficacy is expected to last 5 – 7 years.

* Drug Injury, Liability, Analysis and Prevention, Second Edition, James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.,
Chapter 10, Evaluation of Medical Causation, Donald H. Marks, M.D., Ph.D. , B. Riddell’s criteria, Page 146 , 5. Re-challenge – Re-challenge is the
re-introduction of a treatment, which is then associated with the same or a similar AE, and is a good indication of causation. An AE that does not
recur can signal a lack of causation, but it might also indicate that tolerance has developed. Because just the potential association of a treatment and
an adverse reaction may pre-effect its re-introduction (re-administration of penicillin to a person with a history would be ill-advised, for example), it
is not always possible to use a re-challenge test on a patient.

** IgE binds to basophils (a type of white blood cell) in the bloodstream and mast cells in tissues. When basophils or mast cells with IgE bound to
them encounter allergens (antigens that cause allergic reactions), they release substances (such as histamine) that cause inflammation and damage
surrounding tissues. Thus, IgE is the only class of antibody that often seems to do more harm than good.
Global Parental Concerns Resources
Acquired Immunity – “IgE binds to basophils (a type of white blood cell) in the bloodstream and mast cells in tissues. When basophils or mast cells with IgE
bound to them encounter allergens (antigens that cause allergic reactions), they release substances (such as histamine) that cause inflammation and damage
surrounding tissues. Thus, IgE is the only class of antibody that often seems to do more harm than good.”
“These amounts are higher in people with asthma, hay fever, other allergic disorders…”
http://www.merck.com/mmhe/sec16/ch183/ch183c.html

“Cardiac ischemia happens when an artery leading to the heart becomes narrowed or blocked for a short time and oxygen-rich blood cannot reach
your heart. In most cases of ischemia, this temporary blood shortage to the heart causes pain in the chest (called angina pectoris). In certain other
cases, there is no pain. These cases are called silent ischemia.” http://www.texasheart.org/HIC/Topics/Cond/Cardiomyopathy.cfm

NEW YORK (Dec 20, 2001)


“When a heart attack strikes, the nerve endings in the heart release excessive amounts of the neurotransmitter noradrenaline, leading to arrhythmias, or
disturbances of the heartbeat, with sometimes fatal consequences. In a just-published article in Proceedings of the National Academy of Sciences, two scientists at
Weill Cornell Medical College—Drs. Roberto Levi and Randi Silver—report on studies showing how the activation of a histamine receptor, the H3-receptor, limits
this release of noradrenaline via two independent systems, based on the intracellular concentrations of calcium and sodium.”
http://nyp.org/news/hospital/histamine-receptor-activation.html

“…the fact that the histamine system constitutes one of the most important brain-activating systems and that H3 receptors regulate the activity of histamine and
other neurotransmitter systems. Furthermore, the H3 receptor shows functional constitutive activity, polymorphisms in humans and rodents with a differential
distribution of splice variants in the CNS, and potential coupling to different intracellular signal transduction mechanisms.”
http://www.ncbi.nlm.nih.gov/pubmed/15530639

British Heart Journal, 1979, 41, 426-432, Coronary artery vasospasm: the likely immediate cause of acute myocardial infarction - “Heberden, who first
described angina, to consider it as spasmodic. In his Commentaries (1802), he emphasized the character of the attack, the relation to emotional factors, and the
occurrence of chest pain at rest. '. . . the access and recess of the fit is sudden . . ., it is increased by disturbances of the mind .. . (and) its attacks are often after the first
sleep.‘” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC482050/pdf/brheartj00206-0042.pdf

Possible role of histamine in pathogenesis of autoimmune diseases: Implications for immunotherapy with histamine-2 receptor antagonists, Medical Hypotheses,
Volume 39, Issue 4, Pages 349-355, H. Nielsen, J. Hammer ,
http://linkinghub.elsevier.com/retrieve/pii/030698779290060Phttp://linkinghub.elsevier.com/retrieve/pii/030698779290060P

“Histamine is synthesized in all tissues, but is particularly abundant in skin, lung and gastrointestinal tract. Mast cells, which are present in many
tissues, are a prominent source of histamine, but histamine is also secreted by a number of other immune cells. Mast cells have surface receptors
that bind immunoglobulin E, and when antigen crosslinks IgE on the mast cell surface, they respond by secreting histamine, along with a variety
of other bioactive mediators.” http://www.vivo.colostate.edu/hbooks/pathphys/endocrine/otherendo/histamine.html

Histamine Receptors – “Histamine mediates numerous biological activities stimulated by various immunological and non-immunological stimuli, through
differential expression of H1-4 on effectors’s cells, such as mast cells and basophils. Histamine has a critical role in immunomodulation and allergic diseases. Other
biological activities include cell proliferation, differentiation, hematopoiesis, embryonic development, regeneration, wound healing, aminergic neurotransmission,
secretion of pituitary hormones and regulation of gastrointestinal and circulatory functions.” http://www.tocris.com/pharmacologicalBrowser.php?ItemId=5011
Conclusion
There are several physiological issues that are responsible
for the dramatic increase in adverse event reports for the HPV vaccines.

During the follicular phase of the menstrual cycle, the production of estrogen releases histamine. During the luteal phase the
protective effects of estradiol sharply decline, the production of progesterone increases and the immune system becomes more
easily compromised; succumbing to the overdose of histamine from three sources: L-Histidine in the vaccine, increased
amounts of estradiol in the body from natural production plus environmental toxins (estrogen mimickers) and the body’s own
natural production of histamine.

Both HPV vaccines are VLP’s (virus like particles). This can be termed ‘molecular mimicry’ and when an antigen in a vaccine is
structurally similar to an antigen in the host antibodies are produced that react with the host’s normal tissue.

Allergy sufferers with moderate to severe asthma have IgE levels greater than 1,000 U/ml. Normal serum IgE levels in
individuals without allergies is less than 70 U/ml. An increase in IgE means more free IgE is available for binding to the
activated mast cells. More mast cell activation and degranulation may lead to an increased release of inflammatory histamine.
This reaction also leads to TH2 cytokine and leukotriene secretion, resulting in systemic anaphylaxis in the form of allergy.

This proves an increased risk of injury due to an overload of histamine being released from the mast cells causing a more
severe inflammatory response throughout the body. Tissue damage due to this process can cause hypertrophy of smooth
muscles. Smooth muscles are evident in the heart. With the rechallenge to an already active immune response we could have
more smooth muscle damage especially to the heart and Central Nervous System.

With all our research completed, due to the lack of safety testing in regards to hormone, histamine and IgE level effects due to
challenge and rechallenge on the female and male physiology the risks of the HPV vaccines outweigh the benefits.
Webinar Outcome
On behalf of the parents around the world we are asking that more studies be conducted
on Gardasil and Cervarix before the vaccines are administered to more healthy, innocent
young women and men.

1. Safety study of participants in regards to irregular pap tests and cervical


lesions 2 - 4 years post-vaccination and to be performed by independent entity

2. Review of "new medical conditions" to see if they are resolved or intensified


3 - 4 years post-vaccination and to be performed by independent entity

3. Study on fertility of individuals reporting adverse events

4. Implementation of Menstrual Cycle Evaluation and Guidelines for vaccine


administration for women between menarche and menopause

5. Implementation of additional guidelines to the approval process to include


hormone, IgE and histamine levels to prove safety of product

Copyright © 2010, Freda Birrell, Leslie Carol Botha, Cynthia Janak, Rosemary Mathis, Karen Maynor and
Janny Stokvis

All rights reserved. No part of this power point, including content, design, or graphs, may be reproduced
or transmitted in any form, by any means (electronic, photocopying, recording, or otherwise) without the
prior written permission from the authors.
This website was created by mothers of Gardasil
victims. It is dedicated to the lives who have been lost
and/or altered by this vaccine.